Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-05 @ 3:16 AM
Study NCT ID:
NCT02909361
Status:
UNKNOWN
Last Update Posted:
2022-04-20
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fulvestrant 500mg in Patients With Advanced Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma Sample will be collected at the time of study start and discontinuation base on the clinical practice.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '53 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-09-18', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0', 'timeFrame': 'From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.', 'description': 'Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.', 'description': 'Objective Response Rate'}, {'measure': 'CBR', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.', 'description': 'Clinical Benefit Rate'}, {'measure': 'PFS', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.', 'description': 'Progression Free Survival'}, {'measure': 'OS', 'timeFrame': 'From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.', 'description': 'Overall Survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Fulvestrant 500mg in Patients With Advanced Breast Cancer', 'detailedDescription': 'A multicenter, prospective study real-world to evaluate the safety profile and effectiveness in Chinese patients who received Fulvestrant 500mg as first-line endocrine treatment for Advanced breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer who has already received Fulvestant 500mg treatment as determined by treating physician. Ovarian suppression in premenopausal women is permitted, including ovarian ablation and LHRHa.\n2. Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.\n3. Prior endocrine therapy for advanced disease was not permitted.\n4. The prescription of the Fulvestant is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Fulvestant injection.\n5. Provision of subject informed consent.\n\nExclusion Criteria:\n\n1. If participating in any controlled clinical trial, the subject cannot take part in this study.\n2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.\n3. Pervious regimen of endocrine therapy for advanced disease.\n4. More than one regimen of chemotherapy for advanced disease.\n5. Pregnancy and lactation.\n6. Severe hepatic impairment.'}, 'identificationModule': {'nctId': 'NCT02909361', 'briefTitle': 'Fulvestrant 500mg in Patients With Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Multicenter, Prospective, Real-world Study to Evaluate the Safety Profile and Effectiveness in Chinese Patients Who Received Fulvestrant 500mg as First-line Endocrine Treatment for Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'Fudan BR2016-21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fulvestrant', 'description': '500 mg on days 0, 14, and 28, and every 28 days thereafter', 'interventionNames': ['Drug: Fulvestrant']}], 'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'otherNames': ['Fulvestrant Injection'], 'description': '500 mg on days 0, 14, and 28, and every 28 days thereafter', 'armGroupLabels': ['Fulvestrant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Xichun Hu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of department of medical oncology', 'investigatorFullName': 'Xichun Hu', 'investigatorAffiliation': 'Fudan University'}}}}